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Ropinirole

Generic Medicine Info
Indications and Dosage
Oral
Restless legs syndrome
Adult: For moderate to severe cases: As conventional tab: Week 1: Initially, 0.25 mg once daily for 2 days. If tolerated, may increase dose to 0.5 mg once daily for the rest of the 1st week. Week 2 onwards: 1 mg once daily for 7 days. May further increase in increments of 0.5 mg at weekly intervals up to 3 mg once daily during week 6, followed by a final increase to a Max of 4 mg once daily on week 7. All doses are given 1-3 hours before bedtime. Dose titration must be individualised based on patient's response and tolerability. Treatment recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Parkinson's disease
Adult: As monotherapy or an adjunct to reduce the on-off fluctuations in levodopa response: As conventional tab: Initially, 0.25 mg tid, then may increase in increments of 0.75 mg daily at weekly intervals for the 1st 4 weeks. After 4 weeks, if necessary, the dose may be increased in increments of 1.5 mg daily (up to 9 mg daily) at weekly intervals, then by increments of up to 3 mg daily at weekly intervals for the subsequent weeks. Max: 24 mg daily. As prolonged-release tab: Initially, 2 mg once daily for the 1st week, then increase to 4 mg once daily from the 2nd week. If adequate symptomatic control is not achieved or maintained, the daily dose may be increased by 2 mg at weekly or longer intervals up to 8 mg once daily; if response remains inadequate, the dose may be further increased by 2-4 mg at intervals of at least 2 weeks. Max: 24 mg daily. Use the lowest effective dose of prolonged-release tab that provides adequate symptomatic control. Dose titration must be individualised based on patient's response and tolerability. Patients switching from conventional tab to prolonged-release tab: May initiate dose of prolonged-release tab based on the total daily dose of the conventional tab (refer to detailed product guideline for specific dosing). Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
What are the brands available for Ropinirole in Malaysia?
Special Patient Group
Patients who are initiated on or withdrawn from HRT, CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, fluvoxamine), or CYP1A2 inducers (particularly cigarette smoking) during ropinirole therapy: Dose adjustment may be required.
Renal Impairment
Parkinson's disease:
Patient with ESRD on haemodialysis: As conventional tab: Initially, 0.25 mg tid. As prolonged-release tab: Initially, 2 mg once daily. Max: 18 mg daily. All doses may be increased based on patient's response and tolerability.

Restless legs syndrome:
Patient with ESRD on haemodialysis: As conventional tab: Initially, 0.25 mg once daily; may increase dose based on patient's response and tolerability. Max: 3 mg daily.
Administration
Ropinirole extended-release tab: May be taken with or without food. Swallow whole, do not crush/divide/chew.
Ropinirole tab: May be taken with or without food.
Special Precautions
Patient with significant CV disease, pre-existing dyskinesias, history or presence of major psychotic disorders. Patients who are initiated on or withdrawn from HRT or CYP1A2 inhibitors. Smokers. Avoid abrupt withdrawal. Hepatic and severe renal impairment (including ESRD on dialysis). Pregnancy and lactation.
Adverse Reactions
Significant: New or worsening of dyskinesias, paradoxical worsening of restless legs syndrome (RLS) symptoms (augmentation or early morning rebound), somnolence or episodes of sudden sleep onset, impulse control disorders (e.g. pathological gambling, increased libido, compulsive buying, binge eating), psychotic effects (e.g. agitation, aggressive behaviour, hallucinations, paranoid ideation, delusions, confusion, disorientation, mania), NMS (following abrupt withdrawal); syncope, sometimes associated with bradycardia; hypotension or orthostatic hypotension, fibrotic complications (e.g. cardiac valvulopathy, pericarditis, pleural effusion or thickening, pulmonary infiltrates, retroperitoneal fibrosis); dopamine agonist withdrawal syndrome.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, vomiting, heartburn, abdominal pain, constipation, dyspepsia.
General disorders and administration site conditions: Peripheral oedema (including leg oedema), fatigue, asthenia.
Immune system disorders: Hypersensitivity reaction (e.g. angioedema, rash, pruritus, urticaria).
Infections and infestations: Viral infection.
Musculoskeletal and connective tissue disorders: Back pain.
Nervous system disorders: Dizziness.
Psychiatric disorders: Nervousness.
Respiratory, thoracic and mediastinal disorders: Hiccups.
Patient Counseling Information
This drug may cause excessive sedation or sudden onset of sleep, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood pressure. Assess for signs and symptoms of postural hypotension (particularly during dose escalation in patients with Parkinson's disease), CNS depression or somnolence, and changes in behaviour (e.g. compulsive behaviours). Perform periodic skin examinations.
Overdosage
Symptoms: Nausea, vomiting, increased coughing, dizziness, fatigue, hyperhidrosis, chorea, asthenia, claustrophobia, visual hallucinations, nightmares, dyskinesia, agitation, somnolence, confusional state, palpitations, chest pain, syncope, vasovagal syncope, and orthostatic hypotension.

Management: Symptomatic and supportive treatment. Maintain vital signs if necessary. May administer dopamine antagonists (e.g. neuroleptics, metoclopramide) to alleviate symptoms.
Drug Interactions
Increased serum concentration with CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin, fluvoxamine) and HRT (e.g. estrogen). Neuroleptics and other centrally active dopamine antagonists (e.g. metoclopramide, sulpiride) may reduce the therapeutic efficacy of ropinirole. May cause unbalanced INR when used concomitantly with vitamin K antagonists. May cause additive sedative effects with CNS depressants.
Food Interaction
May enhance sedative effect with alcohol. May decrease the rate of absorption with high-fat meals.
Action
Description:
Mechanism of Action: Ropinirole is a potent, non-ergot derivative D2/D3 dopamine agonist. Its exact mechanism of action is unknown; however, it appears to stimulate the postsynaptic dopamine D2 receptors in the caudate putamen region of the brain.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract (conventional form). Food, particularly high-fat meal, may decrease the rate of absorption. Absolute bioavailability: 45-55%. Time to peak plasma concentration: Approx 1-2 hours (conventional form); 6-10 hours (prolonged-release form).
Distribution: Widely distributed throughout the body. Volume of distribution: 7.5 L/kg. Plasma protein binding: 40%.
Metabolism: Extensively metabolised in the liver by CYP1A2 isoenzyme into inactive metabolites; undergoes first-pass metabolism.
Excretion: Via urine (<10% as unchanged drug, 60% as metabolites). Elimination half-life: Approx 6 hours.
Chemical Structure

Chemical Structure Image
Ropinirole

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 5095, Ropinirole. https://pubchem.ncbi.nlm.nih.gov/compound/Ropinirole. Accessed Sept. 30, 2025.

Storage
Store below 30°C.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BC04 - ropinirole ; Belongs to the class of dopamine agonist. Used in the management of Parkinson's disease.
References
Brayfield A, Cadart C (eds). Ropinirole Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.

Joint Formulary Committee. Ropinirole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/08/2025.

Requip Immediate Release Tablets (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/08/2025.

Requip PD 24 Hour Prolonged Release Tablets (GlaxoSmithKline Pharmaceutical Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/08/2025.

Ropilynz XL 2 mg Prolonged-release Tablets (Lupin Healthcare [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.

Ropinirole 1 mg Film-coated Tablets (Glenmark Pharmaceuticals Europe Limited). MHRA. https://products.mhra.gov.uk. Accessed 06/08/2025.

Ropinirole Hydrochloride. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/08/2025.

Ropinirole Tablet, Film Coated (Alembic Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.

Ropinirole Tablet, Film Coated, Extended Release (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 06/08/2025.

Ropinirole. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 06/08/2025.

Viatris Ltd. Ropin 0.25 mg, 0.5 mg, 1 mg, 2 mg, 5 mg, Tablet data sheet 11 March 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 06/08/2025.

Disclaimer: This information is independently developed by MIMS based on Ropinirole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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